Study on the Effect of Exercise Intervention Combined With Physical Therapy on Chronic Ankle Instability Symptoms

NCT ID: NCT06251414

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-20
• Study Completion Date: 2023-12-30

Brief Summary

Purpose; Through experimental observation of exercise intervention (blood flow restriction training combined with low load ankle muscle strength training and balance training) combined with instrument tool therapy (Instrument Soft Tissue Release Technique, IASTM), the intervention effect on ankle function, strength, and joint range of motion of sports dance athletes with ankle instability was observed.

Method; 45 subjects with unstable, restricted or uncomfortable ankle joints were selected as observation subjects and randomly divided into ankle blood flow restriction training combined with IASTM group (n=15), ankle blood flow restriction training alone (n=15), and traditional ankle strength training (n=15). The intervention lasted for 6 weeks, once a week. Cumberland ankle instability assessment, FAAM ankle function assessment score, and ankle range of motion measurement were performed at three time points before intervention, after the first intervention, and after 6 weeks of intervention for three groups. The ankle strength test was only compared and analyzed at two time points before and after intervention.

Conditions

Chronic Ankle Instability,CA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Blood Flow Restriction Training，BFRT

Blood Flow Restriction Training (BFRT) is a special training technique aimed at limiting blood flow by using cuffs or elastic bands on the limbs to promote muscle growth and improve strength. BFRT was originally designed for rehabilitation injured athletes as it can improve muscle strength while reducing load, helping to avoid further injuries during the rehabilitation process. But as research deepens, it is gradually being applied to a wider range of fitness and training fields. One major advantage of BFRT is that it allows for efficient training under relatively light loads, reducing the burden on joints and tendons, making it suitable for people who find it difficult to withstand high-intensity training due to injuries or other reasons. Meanwhile, BFRT also has the characteristic of achieving muscle growth and strength growth in a short period of time, and it is considered a time-saving training method. BFRT can not only be used for strength training, but also for rehabilitation, i

Group Type: EXPERIMENTAL

Exercise Intervention

Intervention Type: BEHAVIORAL

Blood Flow Restriction (BFR) training, also known as occlusion training or restricted blood flow training, involves applying external pressure to a limb using inflatable cuffs or elastic bands. This pressure partially restricts arterial blood flow while occluding venous blood flow in the pressured limb. The goal is to increase muscle strength and size by creating metabolic stress and promoting physiological adaptations, such as muscle hypertrophy, with lighter loads than traditional resistance training.

Instrument-Assisted Soft Tissue Mobilization，IASTM

Instrument Assisted Soft Tissue Mobilization (IASTM) is a physical therapy technique that utilizes specially designed tools (such as metal or plastic scraping boards) to assist in the treatment of soft tissue problems. Mainly used in rehabilitation medicine, sports medicine, and plastic surgery, it is used to handle tension, adhesion, pain, and motor dysfunction of muscles, fascia, and tendons. The edge design of IASTM special tools can loosen adhesions in tissues, improving their elasticity and plasticity. Regulating pathological areas through neural pathways, reducing pain and improving neurological function. And different types of treatment tools improve the accuracy of treatment, promote blood circulation, accelerate the rehabilitation process, improve tissue elasticity, expand joint range of motion, and have lower risks and complications compared to invasive surgery.

Group Type: EXPERIMENTAL

Instrument-Assisted Soft Tissue Mobilization

Intervention Type: BEHAVIORAL

Instrument-Assisted Soft Tissue Mobilization (IASTM) is a therapeutic technique that involves the use of specially designed tools or instruments to apply controlled mechanical pressure to soft tissues in the body. These tools are typically made of stainless steel or other materials and have various shapes and edges. The primary aim of IASTM is to address musculoskeletal conditions by breaking down scar tissue, fascial restrictions, and adhesions in the soft tissues. Practitioners use the instruments to detect and treat areas of tissue dysfunction, promoting improved range of motion, reduced pain, and enhanced functional mobility.

Tuinal

Tuinal is an important physical therapy method in traditional Chinese medicine, which can be traced back to the Shang Dynasty around 2700 BC. With the continuous development of social economy and cultural exchange, Tuinal technology based on traditional Chinese medicine ethics and guided by modern scientific theories gradually emerged. The technical treatment methods are mainly relaxation techniques, supplemented by movement techniques. Following the principle of combining movement and stillness, emphasizing both muscles and bones, and progressing step by step, massage has significant therapeutic effects on skeletal muscle diseases. In clinical practice, massage therapists use various techniques to apply to specific parts or acupoints of the human body, keeping the nerves and muscle tissues in a good state, improving the unblocking of meridians, relaxing soft tissues, restoring flexibility, and relieving symptoms such as muscle spasms and pain.

Group Type: PLACEBO_COMPARATOR

Tuinal

Intervention Type: BEHAVIORAL

Tuinal, also known as Tui Na or Chinese therapeutic massage, is a traditional Chinese medicine (TCM) healing technique that involves manual manipulation of the body's soft tissues, including muscles and tendons. It is a form of bodywork that aims to balance the flow of vital energy (Qi) within the body and promote overall well-being. Tuina techniques may include kneading, rolling, pressing, and brushing, and they are applied to specific acupressure points or along the body's meridians. Tuina is used to address various health concerns, alleviate pain, improve circulation, and enhance the body's natural healing processes, making it an integral part of traditional Chinese medicine.

Interventions

Exercise Intervention

Blood Flow Restriction (BFR) training, also known as occlusion training or restricted blood flow training, involves applying external pressure to a limb using inflatable cuffs or elastic bands. This pressure partially restricts arterial blood flow while occluding venous blood flow in the pressured limb. The goal is to increase muscle strength and size by creating metabolic stress and promoting physiological adaptations, such as muscle hypertrophy, with lighter loads than traditional resistance training.

Intervention Type: BEHAVIORAL

Instrument-Assisted Soft Tissue Mobilization

Instrument-Assisted Soft Tissue Mobilization (IASTM) is a therapeutic technique that involves the use of specially designed tools or instruments to apply controlled mechanical pressure to soft tissues in the body. These tools are typically made of stainless steel or other materials and have various shapes and edges. The primary aim of IASTM is to address musculoskeletal conditions by breaking down scar tissue, fascial restrictions, and adhesions in the soft tissues. Practitioners use the instruments to detect and treat areas of tissue dysfunction, promoting improved range of motion, reduced pain, and enhanced functional mobility.

Intervention Type: BEHAVIORAL

Tuinal

Tuinal, also known as Tui Na or Chinese therapeutic massage, is a traditional Chinese medicine (TCM) healing technique that involves manual manipulation of the body's soft tissues, including muscles and tendons. It is a form of bodywork that aims to balance the flow of vital energy (Qi) within the body and promote overall well-being. Tuina techniques may include kneading, rolling, pressing, and brushing, and they are applied to specific acupressure points or along the body's meridians. Tuina is used to address various health concerns, alleviate pain, improve circulation, and enhance the body's natural healing processes, making it an integral part of traditional Chinese medicine.

Intervention Type: BEHAVIORAL

Other Intervention Names

Blood Flow Restriction Training，BFRT; IASTM; massage

Eligibility Criteria

Inclusion Criteria

• Age: 18-35 years old
• Course of illness: Suffering from chronic ankle instability symptoms that last for at least 3 months
• Symptoms: Ankle instability, frequent ankle sprains, discomfort during walking or exercise
• Functional screening: Two or more tests tested positive for ankle joint function screening before the experiment
• Structural examination: No joint structural lesions or congenital ankle deformities,
• Medical history: Have not undergone ankle surgery or have external injuries
• Health status: No serious heart, lung, nervous system or other systemic diseases
• Exercise level: Able to complete the exercise intervention and evaluation tasks specified in the experiment
• Agree to participate in the study: Has limited exercise ability and is unable to complete the research task

Exclusion Criteria

• Under 18 years old or over 35 years old
• Acute ankle injury or no joint injury
• No ankle instability or unwillingness to cooperate with research requirements
• Failed ankle function screening
• Structural lesions or congenital ankle deformities present in the ankle joint
• Have undergone ankle surgery or have obvious injuries or wounds
• Serious heart, lung, nervous system or other systemic diseases
• Due to limited athletic ability, unable to complete research tasks
• Disagree to participate in the study, or inability to understand and comply with the research protocol

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yang Liu

OTHER

Sponsor Role: lead

Responsible Party

Yang Liu

doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

YangLiu

Wuhan, Hubei, China

Countries

China

References

Liu Y, Wang Y. Study on the effect of blood flow restriction training combined with IASTAM on ankle strength and function intervention in athletes with chronic ankle instability in sport dance events. BMC Sports Sci Med Rehabil. 2024 Apr 11;16(1):81. doi: 10.1186/s13102-024-00873-x.

Reference Type: DERIVED

PMID: 38605396 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Wuhan Sport University

Identifier Type: -

Identifier Source: org_study_id